1. Slots/Windows of Opportunities HTA – Medical Devices Dr. Wolfgang Ecker EUnetHTA, Rome, 30. 10. 2014

2. Directive 90/385/EEC Active Implantable Medical Devices Directive 93/42/EEC Medical Devices Directive 98/79/EC In-vitro-Diagnostic- Medical Devices Regulation Medical Devices Regulation In-vitro-Diagnostic- Medical Devices 3 D IRECTIVES : > T RANSPOSITION INTO NATIONAL LAW 2 Regulations: > directly applicable EU-legislation

3. Considerable improvement in Clinicals expected:  Notified Bodies – better clinical qualification  Notified Bodies under better EU-scrutiny  Scrutiny procedure (pre-/post-market?)  Clinical Evaluation (MD) – Life cycle process  Performance Evaluation (IVD) – better defined process  Scientific infrastructure: Device/expert Panels; RefLabs  Long term: Registries, PMCF, PMPF  Better clinical transparency But: Still weakness in terminology! (Efficacy? Effectiveness?) MD - Progress on Clinicals 29.10.2014 3 EUnetHTA, Rome, MD-HTA-Slots

4. HTA – MD Interaction: Governance Device/Expert Panels MS Competent and Designating Authorities MD Coordinating Comittee (MDCG) Joint Assessment Team (JAT) (EU Reference Labs for IVDs?) Device Registry evaluations HTA to serve as experts for Expert/Device Panels and/or for MS, MDCG, JAT:

5. Clinical Evaluation Plan + Report Scrutiny Discussion: pre-/post market? 29.10.2014 5 Notified Body Manufacturer MDCG? COM? Clinical Evaluation Assessment Report EUnetHTA, Rome, MD-HTA-Slots Notified Body MDCG? COM? Clinical AUDIT PMCF; Updates of Clinical Evaluation; Recertification Device/Expert Panels + EU RefLabs Clinical AUDIT HTA in agreement with MF/NB or as experts for DP or MS/JAT MS-DA JAT Expert Panel? MS-DA JAT Expert Panel? Pre-Post-market

6. HTA – MD Interaction: Guidance Common Specifications (CS): –Clinical Investigations –Clinical Evaluation –Post Market Follow-up (PMCF) Summary of Safety and Clinical Performance Data (SSPD) Templates Harmonised Standards? HTA as part of Expert/Device Panels could contribute to Guidance for specific device types:

7. HTA – MD Interaction: Training Literature reviews Grading quality of clinical investigations Current state of the art in medicine (HTA, EBM) HTA to cooperate on web-based training for MD-stakeholders

8. Thank You!